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Tests treatment safety and results for Functional Dyspepsia
Official title Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
ClinicalTrials.gov ID: NCT07182890
What this study is testing
What is Clostridium butyricum?
Clostridium butyricum is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for functional dyspepsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group).
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.
- Aged 18 to 80 years, regardless of gender.
- Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.
You likely can't join if
- Use of probiotics or antibiotics within one month prior to the trial.
- Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.
- Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.
- Participation in any other clinical trial within one month prior to the study.
- Positive test for Helicobacter pylori (Hp) infection.
- Long-term use of traditional Chinese herbal medicine.
See the full eligibility criteria
- Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.
- Aged 18 to 80 years, regardless of gender.
- Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.
- Use of probiotics or antibiotics within one month prior to the trial.
- Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.
- Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.
- Participation in any other clinical trial within one month prior to the study.
- Positive test for Helicobacter pylori (Hp) infection.
- Long-term use of traditional Chinese herbal medicine.
- Pregnancy or lactation.
- History of drug abuse.
- Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic...
- History of major surgery or diagnosis of diabetes mellitus.
- Refusal to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Xi’an, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi’an, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.